The Evolution of Public Health Research—A Summary of the Blog Series

Over the past year, we presented a series of blog posts on The Evolution of Public Health Research, our salute to a profession and area of study that has not only saved many, many millions of lives, but also dramatically improved the length and quality of life as well.

Controlling Preanalytical Variability in Biospecimen Collections

Large, well-designed population studies and the interrelationships they reveal are the backbone of public health and serve as a foundation for medical research. The health and lifestyle information of participants, collected via questionnaire and linked to their biospecimen samples, allow investigators to examine the intricate relationships between genetics, physiology, behavior, environment, and disease.

Maximizing the Value of Biospecimens to Deliver New Therapies

In his position as Director and Head of Sample Management, Dr. Green is faced with a number of challenges, including AstraZeneca's transition from their research and development center in northwestern England, to a new research center to be built in Cambridge. The greater challenge going forward is, from Dr. Green's perspective, maximizing value from the biospecimens in the collection. This involves, among other issues, closing the gap in inventory management methods between the small molecule world and the world of biospecimens.

In this interview, Clive shares his perspective on biobanking, as it compares to managing a small molecule inventory, and challenges in the biospecimen supply chain.

This eBook goes beyond the basics and acquaints you with some of the lesser known considerations. Although they may be hidden in the background, these factors can play a major role in the success or failure of a clinical trial and the long term efficacy of a cell-based commercial product. They are:

Standardization

Package and shipping qualification

Equipment validation

Process qualification

Documenting the chain of custody

I am focusing this eBook on the unique logistical challenges of autologous cell-based therapies, that is, therapies that use a patient’s own cells for the manufacture of a treatment that is then administered only to that patient. The other type of cell-based therapy is referred to as“allogeneic” and is derived from an unrelated donor or donors, and administered to the relevant population of patients. All of the considerations I mentioned above apply to allogeneic as well as autologous therapies.

Standardizing Biosample Management: Why Use Collection Kits?

Whether you are conducting a phase 3 clinical trial of a new therapy or looking for biomarkers, you will need to collect samples, and that leads to a number of questions. How do you collect the biosamples in such a way as to preserve their usefulness—maintain molecular integrity—for your specific (or unknown) downstream analyses and assays? How many samples will be needed, how many “collectors” will be involved, and how many locations? How long do the samples have to be preserved, and how will they be stored? And how will you manage the data?

Here are some basics to help with planning sample collection and to help make the process as cost-effective as possible.

Smart Biobanking: From Samples to Predictive Algorithms for Detecting Cancer

The recently released World Cancer Report 2014, a global analysis by the World Health Organization, noted both the increase in cancer cases worldwide, as well as the burden represented by the spiraling cost of treating late stage disease. The report, as stated in the preface, makes it clear that we cannot “treat our way out of cancer.”

The most effective approach to addressing cancer is prevention, and if treatment is necessary, it is best at an early stage, which is associated with much higher survival rates as well as lesser side effects. Ovarian cancer is a case in point: Five-year survival among women diagnosed with stage 4 disease is 5.6 percent, while those diagnosed and treated at stage 1 is as high as 92 percent. However, early treatment depends on early diagnosis, and in spite of major investments of both resources and effort, there are still few biomarkers available for the diagnosis of cancer at a very early stage, when the disease is far more treatable.

Extreme Biobanking: How to Build and Operate a -80°C Walk-In Freezer

Opening a door and walking into the equivalent of Antarctica takes preparation. Scientists studying climate can use instruments to measure extremely cold temperatures: NASA documented the lowest temperature on record, -93.2°C, in 2010 from a high ridge on the East Arctic ice sheet, using satellite data. But what if instruments won’t do the job? What if your employees have to work in such an environment?

Managing the distribution of clinical agents for large, multi-site, multi-country clinical trials requires a spectrum of expertise and infrastructure, specifically designed to ensure accuracy in order processing and preservation of the integrity of the product from initial receipt into inventory through delivery to the clinical site.

Next Generation Cohort Studies and Biobanking: How Cloud Technology is Accelerating Translational Research

Cutting edge technology and innovations in molecular epidemiology are usually associated with the laboratory. However, the California Teachers Study (CTS), a prospective epidemiology cohort study, is making use of a different cutting edge technology. The CTS is using mobile devices and cloud-based technology to dramatically cut the time and cost of managing the huge amounts of data that are the cornerstone of epidemiological studies.

European health care systems, as elsewhere, are striving to meet the challenge of caring for a growing number of seniors. By 2050, the number of people over 65 in the EU will increase by 70 percent, and the number of people over age 80 will grow by 170 percent. Therapeutic interventions that are effective, affordable and well-tolerated in the prevention of chronic disease could have an outstanding impact on public health as a whole and are urgently needed.

How do you determine if your inventory is automation-friendly? Chances are, if you didn’t launch your biobank with automation in mind, or if a large percentage of your inventory is legacy collections, you’ve got some serious challenges ahead of you. If your focus is managing labor costs, automation may or may not be all or part of the answer. As a starting point, give considerable thought to the issues presented here.